Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1355-2013 — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

U.S. FDA — Device Enforcement · United States · 2013-04-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1355-2013
Date of alert: 2013-04-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Progressive Medical Inc
Product category: device
Product type: Devices

Reported risk: Product coatings require 510K approval.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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